[unreadable] The current controversy surrounding the benefits of mammography has highlighted the need for greater specificity in diagnosing breast cancer. SciTech Development LLC (SciTech) scientist, in conjunction with the Karmanos Cancer Institute (KCI), has been developing a new Computerized Ultrasound Risk Evaluation (CURE) system that utilizes tomographic reconstructions of both reflected and transmitted ultrasound data, yielding images that rival the spatial localization of CT and the tissue detail of MRI. CURE's "proof of concept" study, utilizing an engineering prototype, indicates that it generates greater tissue contrast and margin detail while allowing for low frequency, deep penetration, whole breast imaging. Using the new clinical prototype scanner, we will confirm that we can acquire tomographic breast images providing 3D localization and high diagnostic image quality from a combination of reflectivity, sound speed and attenuation. During Phase II, SciTech proposes to test 200 breast cancer patients to demonstrate that we can detect previously identified breast masses in order to establish a solid niche for Computerized Ultrasound Risk Evaluation (CURE) in a standard diagnostic evaluation. In order to reduce the risk of conducting this major clinical study, we first propose to complete specific aims designed to test the improved performance capabilities of reflection and transmission ultrasound imaging utilizing our clinical scanner in-vitro and in-vivo. This Phase I risk reduction activity will validate the fact that an in-vivo scanner yielding significant improvements in breast imaging specificity can function as expected while leading to medical and commercial support for testing such a device. Continued risk reduction activity will encourage further product development investment, thus leveraging the impact of Federal grant support for this promising technology. [unreadable] [unreadable]